C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808060 |
Device Problems
Disconnection (1171); Difficult to Flush (1251); Material Separation (1562); Suction Problem (2170); Device Dislodged or Dislocated (2923)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
Event Type
Death
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 02/2016).
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Event Description
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It was reported that during a port placement procedure, the port allegedly not able to get blood return and flush into the port.It was further reported that the needle came out during infusion.There was no reported patient injury.
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Event Description
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It was reported that during a port infusion treatment procedure, the port was allegedly unable to obtain a blood return and unable to flush.It was further reported that the needle came out during infusion treatment.Reportedly, a few days later, the patient was transported to the emergency room, the port was flushed and aspirated successfully.Approximately one month later the patient reportedly expired.The cause of death is unknown.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history record was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H6 device codes.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a port infusion treatment procedure, the port was allegedly unable to obtain a blood return and unable to flush.It was further reported that the needle came out during infusion treatment.Reportedly, a few days later, the patient was transported to the emergency room, the port was flushed and aspirated successfully.Approximately one month later the patient reportedly expired.The cause of death is unknown.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history record was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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